SBIR Phase I: An Injectable Treatment for the Repair of Damaged Tendons and Ligaments

Regenx Llc, Nashua

Investigators

Abstract

The broader impact of this Small Business Innovation Research (SBIR) Phase I project will be improvement of quality of life and reduction of healthcare costs associated with tendon and ligament injuries which are notoriously difficult and slow to heal, depriving millions of Americans years of productivity. Tendon and ligament injuries are especially debilitating for the aged, the active or those with physically demanding professions. Injured ligaments (e.g. anterior cruciate ligament) or tendons (e.g. Achilles) require months of rehabilitation and can take up to a year to heal. In the elderly, rotator cuff injuries are pernicious, prevalent and refractory to treatment. Every year in the US, $130 billion is spent on musculoskeletal injury-related medical visits, 60% of which are tendon and ligament injuries. Tendon and ligament injuries result in 288 million lost work days costing the US economy $50 billion annually. In spite of decades of effort, there has been very little improvement in either the rate or the quality of healing for these injuries. The injectable repair system proposed could reduce healing time and improve repair quality. The proposed plan to drastically reduce the cost of the raw materials through human cell engineering will make the treatment solution universally affordable. The proposed project will determine the feasibility of an entirely new approach to tendon and ligament repair based upon the in vivo delivery and assembly of collagen monomers into the path of force. The approach is derivative of two recent innovations that will be combined in four objectives to produce an injectable collagen-based solution designed to accelerate the repair of damaged connective tissues (i.e. ligaments and tendons) the healing of which presents a significant medical challenge. The first innovation is the use of CRISPR/CAS9 technology which will be used to accelerate the production of collagen by human fibroblasts. Objective 1 will to optimize the CRISPR process and scale it up through isolation and expansion of cells receptive to enhanced collagen production. Objective 2 will leverage the second major innovation, liquid crystal collagen processing technology, to develop a shelf stable injectable solution of highly-dense particulates that is expected to donate large amounts of collagen to injured connective tissue. Objective 3 will demonstrate that the injectable repair solution will deliver collagen to repair damage in vitro and Objective 4 will apply the approach in vivo, to demonstrate that exogenous collagen delivery can speed the repair of damaged, living tendon. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.